The Cervical Plate is intended for anterior interbody screw fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during development of a solid fusion in patients with the following conditions:

degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies),
spondylolisthesis,
trauma (i.e., fracture or dislocation),
spinal stenosis,
deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
tumor,
pseudoarthrosis, and
failed previous fusion.
Warning: This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

Device Description

The Cervical Plate system consists of multiple sized plates and screws. All components are fabricated from anodized titanium alloy (Ti-6Al-4V) that conforms to ASTM F136. Fixation is provided by inserting screws through holes in the plate into the vertebral bodies of the cervical spine.
The screws utilized in the Cervical Plate are of the self tapping cortical type and are available in 04.0mm and a variety of lengths.

AI/ML Overview

The provided text describes a 510(k) submission for a medical device called "Cervical Plate." This submission details the device's design, intended use, and its substantial equivalence to a previously marketed device. However, it does not include information about acceptance criteria or a study that proves the device meets specific performance criteria in the way a clinical or in-vitro diagnostic study would.

Instead, the submission focuses on demonstrating "substantial equivalence" to a predicate device, which is a different kind of regulatory pathway. The "Summary Nonclinical Tests" section mentions "Testing was performed according to ASTM F1717," which refers to a standard for mechanical testing of spinal implant constructs. This typically involves biomechanical or material testing rather than assessing performance against clinical acceptance criteria.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study proving the device meets them because the provided text does not contain this information. The documents are focused on regulatory approval via substantial equivalence based on design similarity and mechanical testing to an ASTM standard, not a clinical performance study with acceptance criteria.

To elaborate on why I cannot provide the requested information:

Acceptance Criteria Table & Reported Device Performance: This type of table would typically present metrics like sensitivity, specificity, accuracy, or other clinically relevant measures and compare them against predetermined thresholds. This information is absent.
Sample Size for Test Set & Data Provenance: This would refer to patient data used in a clinical study. The document does not describe such a study.
Number of Experts & Qualifications for Ground Truth: This is relevant for studies involving human interpretation or diagnosis. Not applicable here.
Adjudication Method: Also relevant for studies with human interpretation. Not applicable here.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: This is for evaluating AI-assisted performance compared to human readers. Not applicable as this is a physical medical device, not an AI diagnostic tool.
Standalone Performance Study: This would describe the performance of an algorithm without human intervention. Not applicable.
Type of Ground Truth: This would be clinical outcomes, pathology, expert consensus, etc. Not applicable to the information provided.
Sample Size for Training Set: This is for machine learning models. Not applicable.
How Ground Truth for Training Set was Established: Again, for machine learning. Not applicable.

The provided text focuses on the device's physical and mechanical characteristics, its intended use, and its similarity to an existing device, along with adherence to a mechanical testing standard (ASTM F1717), which is a common approach for spinal implants to demonstrate safety and efficacy through mechanical performance rather than clinical performance against specific disease-related acceptance criteria.

Summary

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SEP 2 4 2004

Cervical Plate 510(k) Summary August 24, 2004

Submitter Scient'x Batiment Calypso Parc Ariane 3 78284 Guyancourt FRANCE Contact person J.D. Webb 1001 Oakwood Blvd Round Rock, TX 78681 512-388-0199 Trade Name Cervical Plate Common name Anterior cervical plate Classification name Class II per 21 CFR section 888.3060 Product Code KWQ Equivalent Device Scient'x Anterior Cervical Plate (K013439).

Device Description

The screws utilized in the Cervical Plate are of the self tapping cortical type and are available in 04.0mm and a variety of lengths.

Intended Use

· degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies),
· s pondylolisthesis,
· trauma (i.e., fracture or dislocation),
· s pinal stenosis.
· d eformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
tumor,
· p seudoarthrosis, and
· failed previous fusion.

However, this device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine

Summary of Technological Characteristics Compared to Predicate Device

The Cervical Plate is similar in indications, material, design, geometry, screw locking mechanism, length, strength, and screw diameter, length and thread form.

Summary Nonclinical Tests

Testing was performed according to ASTM F1717.

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Image /page/1/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or other bird-like figure. The symbol is composed of three curved lines that form the shape of the bird's head, body, and tail.

Public Health Service

SEP 2 4 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Scient'x C/o Mr. J.D. Webb The OrthoMedix Group, Inc. 1001 Oakwood Blvd. Round Rock, Texas 78681

Re: K042317

Trade/Device Name: Cervical Plate Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: August 24, 2004 Received: August 26, 2004

Dear Mr. Webb:

We have reviewed your Section 510(k) premarket notification of intent to market the device wo nave roved above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass surver in the encreases 976, the enactment date of the Medical Device Amendments, or to conniner of the ria) 2011-12-11 in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, aroney manager of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your de rice to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r reaso or as made a determination that your device complies with other requirements of the Act than - Drideral statutes and regulations administered by other Federal agencies. You must or any i vith all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. J.D. Webb

This letter will allow you to begin marketing your device as described in your Section 510(k) I mo reter will and wy of substantial equivalence of your device of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Macer Eccurers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark A. Millman

Celia M. Witten, PhD, MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): _长۵५2 317

Device Name: Cervical Plate

Indications for Use:

· degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies),
· spondylolisthesis,
· trauma (i.e., fracture or dislocation),
· spinal stenosis,
· deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
tumor,
· pseudoarthrosis, and
· failed previous fusion.

Warning: This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mulh A. M. M
(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

510(k) Number K042317

Regulation Number and Section

§ 888.3060 Spinal intervertebral body fixation orthosis.

(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.